Laparoscopic surgery (also known as key-hole surgery or minimally invasive surgery) utilizing small surgical incisions has become a widely popular procedure of choice for many diseases and conditions involving various organ systems in recent years, as it has been shown to provide decreased perioperative patient morbidity. Laparoscopic cholecystectomy (gall bladder removal), appendectomy (appendix removal), hysterectomy (uterus removal), and nephrectomy (kidney removal) are some of the examples. The laparoscopic surgical wounds, although small in size, generally require suture closure to prevent the formation of hernia, in which an intra-abdominal structure such as bowel protrudes through and can be entrapped at the wound site. The incidence of hernia at unclosed laparoscopic wound sites has been reported to be up to 5-6% in the medical literature, and these hernia cases have been often associated with bowel complications requiring reoperation. Even if there is no associated discomfort or bowel entrapment, hernias generally require surgical closure to minimize the risk of potential bowel emergency. Consequently, closure of the laparoscopic trocar wounds, especially those ≥10 mm in size, is generally recommended.
In the closure of the laparoscopic wound sites (from laparoscopic trocar puncture), it is important to close the fascial layer defect, which is located below the skin and subcutaneous fatty layer. The fascia provides most of the strength to the body wall and is the most important layer to close. Peritoneum (the inner most layer of abdominal wall and comes in direct contact with intra-abdominal structures such as bowel) is also important to close as there are reported cases of bowel hernia in obese patients after fascial closure alone. Incorporating the fascial layer and the peritoneal layer in the wound closure constitutes a full-thickness closure, which is the optimal method.
Small surgical wounds from laparoscopic trocar sites are typically closed via open surgical techniques (by directly identifying and hand suturing of the body tissue layers using the conventional open surgical instruments) or via certain medical devices such as Carter-Thomason Suture Passer CloseSure Device (from Inlet Medical), various double-headed needle-tip suture threading and capture devices, and various single-headed needle-tip suture passing and capture devices (See U.S. Pat. Nos. 5,953,734, 5,496,335, 6,183,485, 7,320,693, 5,562,688, 5,281,234, 5,222,508, 5,503,634, 5,336,239, 5,507,755, 5,320,629, 5,281,237, 5,817,112, 5,499,991, 5,468,251, 5,439,469, 5,350,385, 5,403,328, 5,653,717, 5,387,227, 5,149,329, 5,433,722, 5,462,560, 5,374,275, 5,368,601, 5,320,632, 5,403,329, 5,458,609, 5,626,558, 5,507,757, 5,368,601, 6,500,184, 6,066,146, 5,085,661, 5,626,614, 5,041,129, 5,354,298, 6,488,691, 5,391,182 and published patent application number 20050043746A1, 20040249412A1, 20040087978A1). Open surgical closure is often difficult and time-consuming due to the small size of the incisional opening and the significant depth of the incision. The various medical devices for laparoscopic wound closure listed above were designed to reduce the efforts and closure time needed. Of these, Carter-Thomason system is the most popular. However, full thickness closure (incorporating different body wall layers including the peritoneum and fascial layer except the skin) in a timely manner is often unreliably or inconsistently achieved clinically. In addition, some of the devices may he expensive to manufacture. None of these clinically available devices describe or suggest the present invention Furthermore, none of the wound closure devices patented previously yet not used clinically describe or suggest the present invention.
There is clearly a long-felt need for devices and methods that provide reliable full-thickness tissue closure at the small surgical wounds such as those in laparoscopic surgery. There is a need for such devices and methods to provide small surgical wound closure in a safe and fast manner. There is a need for such devices that are simple and inexpensive to manufacture, that are simple to use and robust in use, and that can be used with a variety of wound sizes, configurations, and depths. The present invention provides such devices and methods of using them.
Exemplary embodiments of the invention are described in detail by the figures and by the description below.